Miao 2014.

Methods	Type of study: single‐centre, parallel‐group randomised controlled trial. Full‐text paper Country: China Dates of trial (start and end): February 2013 to October 2013 Follow‐up until: until hospital discharge
Participants	Inclusions: 1. Children aged 6 months to 3 years undergoing cardiac surgery with CPB for congenital cyanotic heart disease Exclusions: 1. Haemoglobin less than 150 g/l 2. Known coagulation disorders 3. Renal insufficiency 4. Hepatic insufficiency 5. Anticoagulant medications 6. Previous cardiac surgery procedures 7. Emergency surgery 8. Critically ill patient Age: Intervention arm: mean 15.6 months (standard deviation 7.7 months) Comparator arm: mean 14.7 months (standard deviation 8.1 months) Ethnicity: Not reported Gender: Intervention arm: 24 male and 22 female Comparator arm: 27 male and 18 female Operations: Intervention arm: elective surgery only; all patients had cyanotic heart disease Comparator arm: elective surgery only; all patients had cyanotic heart disease
Interventions	Intervention arm: Transfusion of 10 to 20 ml/kg FFP with CPB priming (n = 46) Comparator arm: Transfusion of 10 to 20 ml/kg gelofusine with CPB priming (n = 45)
Outcomes	Primary: Change in haemostatic parameters measured by thromboelastography postoperatively Other outcomes: 1. Postoperative blood loss 6 hours and 24 hours postoperatively and total blood loss before discharge 2. Red cell transfusions postoperatively 3. Platelet transfusions postoperatively 4. Need for pharmacological agents (prothrombin complex concentrate and fibrinogen concentrate) to control bleeding postoperatively 5. ICU admission duration 6. Total length of hospital admission 7. Return to theatre during admission 8. Renal function postoperatively
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